Glipizide

Product NDC
0378-1105
11-digit product format
003781105
Labeler code
0378
Product ID
0378-1105_e7c9f6a0-504a-4f2b-afaf-2fa93b442b86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074226
Marketing category
ANDA
Marketing start
1994-05-10
Marketing end
2023-08-31
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-1105DDiscontinued by firm2026-08-17
excluded packagepackage0378-11050378-1105-01DDiscontinued by firm2026-08-17
excluded packagepackage0378-11050378-1105-05DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-1105-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-1105-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-1105-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-1105-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-1105-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-1105-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-1105-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-1105-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-1105-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-1105-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-1105-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-1105-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-1105-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-1105-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-1105-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-1105-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-1105-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-1105-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-1105-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-1105-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-1105-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-1105-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-1105-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-1105-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074226-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORALAB1994-05-10
A074226-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORALAB1994-05-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074226-001AB
A074226-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074226-001GLIPIZIDE5MGTABLET / ORALAB1994-05-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074226-002GLIPIZIDE10MGTABLET / ORALAB1994-05-10bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074226-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074226-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074226-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074226-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074226-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074226-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074226-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074226-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074226-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074226-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074226-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074226-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074226-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074226-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074226-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074226-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074226-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074226-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074226-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074226-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074226-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074226-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074226-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074226-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074226-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074226-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074226-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074226-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074226-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074226-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074226-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074226-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074226-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074226-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074226-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074226-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074226-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074226-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074226-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074226-002AB1bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1105-01EA - Each0378-110519e02aa9-75a7-49e0-810b-c4ca544192a912012-07-24
0378-1105-05EA - Each0378-110556eafd96-a872-48cd-bde2-be7858f4708112012-07-24

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1105-0100378110501100 TABLET in 1 BOTTLE, PLASTIC (0378-1105-01) 100 tablet1994-05-102023-08-31NoNoCurrent
0378-1105-0500378110505500 TABLET in 1 BOTTLE, PLASTIC (0378-1105-05) 500 tablet1994-05-102023-08-31NoNoCurrent